With the help of highly experienced staff, Creative Biolabs now provides gene integration stability tests for recombinant strains with a fast turnaround time. Our expertise in complex method development and validation for gene integration stability test can give you a detailed insight into your biologic, helping to accelerate your development process for your live biotherapeutic products.
Gene integration stability testing is a key component and a regulatory requirement for characterization live biotherapeutic products production. Genetic elements integrate transgenes into the host genome of recombinant strains in a random manner. During subsequent strain culture, genomic events such as deletions, rearrangements, and point mutations may occur and result in an altered phenotype and/or gene expression profile. The instability of these recombinant strain products is of great concern as it may negatively impact product integrity, posing a risk to patients. Therefore, it is crucial to know the stability and integrity of the insertion sequence, which is characterized to ensure the stable production of the correct recombinant strains.
A unique aspect of engineered recombinant strain products is the need to ensure gene integration and genetic stability during the production of strains. Creative Biolabs will investigate the integrity and homogeneity of the recombinant bacterial genome or plasmid and the genetic stability of the bacterial vector and therapeutic sequence. Our gene integration stability testing will verify that the recombinant strain system has not undergone any changes that would impact the integrity of the products. Our team of scientists can develop gene integration stability tests specific to your biological products.
The analysis starts with the isolation of enough clones to adequately sample the population of cells in the culture. Creative Biolabs offers a series of molecular and microbial assays as following that can be applied to evaluate genetic stability of the integration site of an expression construct and can advise you on the most appropriate approach for your recombinant strain products:
Furthermore, custom gene integration stability tests can be prepared upon request at Creative Biolabs. Through our tailored approach, we maximize the efficiency of study design, bringing cost-efficiencies and time-saving benefits.
At Creative Biolabs, we provide a full range of assays for the characterization of recombinant strains, and all services are tailored to our client's specific needs. A team of scientists at Creative Biolabs can work with you to figure out the best way to optimize your live biotherapeutic products. We are dedicated to timely, high-quality services from the start of your project to the finish. Please send us a note or give us a call to find out what Creative Biolabs can do for you.
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